1. Recruitment of egg donors by South Korean stem cell researchers Created by the IDEESE Project, 2009 You are free to use and modify these slides under a Creative Commons, Attribution-Noncommercial-Share Alike License Funding for the International Dimensions of Ethics Education in Science and Engineering (IDEESE) Project comes from the National Science Foundation (NSF) through grant number 0734887. Any opinions, findings, conclusions or recommendations expressed here are those of the author(s) and do not necessarily reflect the views of NSF.

2. What are Stem Cells? Stem cells are undifferentiated cells in the bodies of humans and animals able to replenish themselves by dividing and capable under particular natural or medically- induced circumstances of developing into the more specialized cells that form bones, nerves, body tissue, brains, muscles or blood.

3. Why are Stem Cells Important? 1.Studying stem cells reveals more about the processes of normal and abnormal cell development, providing knowledge with potential for treating cancer and birth defects arising from faulty cell division. 2.Stem cells offer the possibility of regenerative therapy for a range of diseases and conditions because they can develop into any body part. 3.Stem cells can be used for therapeutic cloning to correct life-threatening genetic defects.

4. Basic Ethical Controversies Some observers worry that stem cell use will lead to cloning of humans or producing “designer babies.” An embryo must be destroyed in the process of securing its stem cells, and anyone who believes that human life begins at the moment a sperm fertilizes an egg regards destroying embryos as committing murder.

5. Early Stem Cell Use Somatic (“adult”) stem cells were first identified in bone marrow in the 1960s and used for treatments of leukemia, aplastic anemia, and some immune system deficiencies. Embryonic stem cells were first derived from mouse embryos in 1981, and from human embryos in 1998.

6. International Guidance in 2002 Nuremerg Principles (1947), Helsinksi Declaration (2002 rev) and ICH-GCP –Apply to any form of stem cell research that begins with securing stem cells from human body parts or embryos –Cover the process of securing eggs and sperm needed to produce human embryos Human subject protection Informed consent

7. South Korean Regulations in 2002 Did not address permissible and impermissible types of genetic research, cloning or stem cell research Did include provisions for human subject protection The Korean Food and Drug Administration did oversee the use of human subjects in commercial research projects, including clinical trials, but its authority did not extend to human subjects in scientific research Did ban donations from junior members of research teams, but did not specifically ban payment to eligible donors

8. General Scientific Opinion in 2002 Consensus that undergraduate and graduate students, junior members of research teams, and other employees over whom researchers have supervisory authority should not be used as donors for research because of the potential for coercion No consensus on whether egg donors could be paid

9. Dr. Hwang Woo-suk - Biography Veterinary science faculty member at Seoul National University, South Korea One of South Korea’s leading stem cell researchers 1999: Claims to have cloned cows 2002-2005: Pursues cloning of human and animal embryonic stem cells

10. Ethical Controversies over Dr. Hwang Woo-suk’s research 1.General public uneasiness about cloning human embryos –12 countries had banned all forms of human cloning by this time 2.Questions circulate about how Hwang recruited egg donations from women starting in January 2004 3.Claims that 2 to 5 of Hwang’s papers contained fabricated data surface in late 2005

11. Public Support for Dr. Hwang Woo-suk in November 2004 800 women volunteer to donate eggs within a week of an appeal for donors After showing a news program about the egg donation controversy, Munhwa Broadcasting is accused of being unpatriotic, is picketed by angry demonstrators, receives threats to the producers of the program, and loses advertisers Hwang supporters insist that the controversy reflects an unfair imposition of Western standards on Korean researchers

12. Controversy Intensifies Claims of data fabrication prompt additional media coverage Seoul National University convenes a 9- scientist internal review panel to look into ALL of the charges against Hwang in December 2005

13. Review Panel Findings Confirms charges of data falsification Confirms irregularities in procurement of egg donations Rejects Hwang’s claim that he was not aware of egg donations by females on his research team; notes testimony that he –distributed consent forms in the lab –gave one of the researchers a ride to the hospital for the egg donation procedure

14. Discussion Western or Global Values? In what ways were Hwang supporters correct in claiming the egg donation controversy forced Western standards on Korean researchers? In what ways were they incorrect? What are the sources of these differences in perception of the situation?

15. Discussion Impact of the Global Political Structure In what ways does this case highlight global political decentralization in regulation and implementation? What impact does such decentralization have on scientific innovation and research?

16. Discussion Internationalizing Science How does this case reflect the internationalization of science? What influence did researchers, ethicists, or others from other countries have in the growing controversy and on Seoul National University’s decision to establish a special review board to investigate the charges?

17. Discussion Protection of junior researchers What policies are in effect today to prevent coercion of subordinates by superiors? What enforcement powers exist? What happens if these policies vary across countries?